Kornimate/medical-research-clean huggingface dataset:
prevail-tf: transfemoral placement of aortic balloon expandable transcatheter valves trial (europe)

Conditions: Aortic Valve Stenosis

Summary: a single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the edwards sapien xt™ transcatheter heart valve (model 9300tfx; "study valve"), its transfemoral delivery system, and crimper accessories. the trial includes a premarket confirmatory cohort to evaluate the system performance as well as a post market clinical follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

edwards lifesciences obtained ce marking authorization for transfemoral delivery / implantation of the edwards sapien™ transcatheter heart valve (model 9000tfx) using the retroflex™ delivery system in august 2007 and introduced these devices for commercial distribution in the european economic area (eea) in october 2007. clinical sites: up to 11 sites in europe

Eligibility criteria:
inclusion criteria: all candidates for this study must meet all of the following inclusion criteria: 1. patients must have co-morbidities such that the surgeon (co investigator) and interventional cardiologist (principal investigator) concur that the predicted risk of operative mortality is \> 15% with a minimum sts risk calculator score of ≥ 10 and/or logistic euroscore of \> 20%. 2. patient is symptomatic from his/her aortic valve stenosis, as demonstrated by nyha functional class ii or greater. 3. the subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing ethics committee (ec) of the respective clinical site. 4. subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography. 5. the subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. exclusion criteria: 1. aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified. 2. mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+). 3. any therapeutic invasive cardiac procedure, other than bav, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).

Keywords: sapien valve cardiovascular diseases valvular heart disease aortic stenosis heart valve therapy transfemoral transcatheter
risk stratification value of biomarkers in patients with myocarditis

Conditions: Myocarditis

Summary: the aim of this study is to collect clinical data and biological specimens from patients with myocarditis and construct a predictive model for the prognosis of myocarditis.

the aim of this study is to retrospectively and prospectively collect clinical data and biological specimens from patients with myocarditis who meet the inclusion and exclusion criteria. general molecular biology analysis, genome sequencing, transcriptome sequencing, methylation sequencing, metabolomics analysis, proteomics analysis, genome-wide chromosome conformation capture and other techniques are used to construct a prognosis prediction model for myocarditis.

Eligibility criteria:
inclusion criteria: * all patients should meet the diagnostic criteria for myocarditis * patients who are regularly followed up at the corresponding cardiovascular center exclusion criteria: * age \ 80 years * pregnant or lactating women * the patient refused to sign the informed consent and refused to participate in the study * none of the above is consistent, but the patient cannot sign the informed consent temporarily due to coma and other reasons, and there is no legal representative to sign it instead. depending on the condition, the patient may not wake up to sign the informed consent

Keywords: myocarditis biomarker risk stratification
a safety and efficacy study of sb1518 for the treatment of advanced lymphoid malignancies

Conditions: Hodgkin Lymphoma; Mantle Cell Lymphoma; Indolent Lymphoma

Summary: this is a phase 2 study to assess the efficacy of sb1518 in the treatment of patients with advanced lymphoid malignancies including hodgkin lymphoma, mantle cell lymphoma and indolent lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).


Eligibility criteria:
inclusion criteria: * patients with histologically documented diagnosis of one of the following lymphoid malignancies: * hodgkin lymphoma; * mantle cell lymphoma; * indolent lymphoma (including follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma); * patients must have received at least one prior treatment regimen; patients with hodgkin lymphoma must have received an autologous stem cell transplant, refused or been deemed ineligible for stem cell transplant; * able to understand and willing to sign the informed consent form. exclusion criteria: * any histology other than hodgkin lymphoma, mantle cell lymphoma or indolent lymphoma; * history of or active central nervous system (cns) malignancy; * active graft-versus-host disease (gvhd);

Keywords: lymphoid malignancies hodgkin lymphoma mantle cell lymphoma indolent lymphoma sb1518
a novel approach for horizontal augmentation: a split box

Conditions: Alveolar Bone Loss; Alveolar Ridge Augmentation; Augmentation, Alveolar Ridge

Summary: the goal of this clinical study is to investigate the effectiveness of the split-box technique in systemically healthy, non-smoking, over 18 years of age, participants with narrow crests (\ 12mm). the main questions it aims to answer are: * the primary objective of the present study is to investigate the effectiveness of the split-box technique by evaluating the change in width and height of the alveolar bone. * the secondary objective is to evaluate the superiority of the split-box technique and its modifications in terms of the amount of bone gain. according to the 3d topography of the alveolar ridge of the patients before augmentation, split box or one of its modifications, reverse split box or sliding split box techniques were selected and applied. (split box was applied if the bone thickness was more than 3 mm at the top of the crest and did not increase towards the lower border at the alveolar bone, reverse split box technique was applied if the bone thickness was more than 3 mm at the top of the crest and increased towards the lower border at the alveolar bone, sliding split box was applied if the bone thickness was less than 3 mm at the top of the crest but the bone thickness increases towards the lower border at the alveolar bone.)


Eligibility criteria:
inclusion criteria: * to be older than 18 years of age * to be systemically healthy * to be non-smokers * having narrow crests (\<5 mm bone width) * having adequate bone height (\>12 mm) * having cone-beam computed tomography scans before surgery and five months after augmentation exclusion criteria: * having bone diseases, * a history of neck or head radiotherapy * receiving steroids, bisphosphonates or chemotherapeutic drugs * being pregnancy * having narrow bone thickness in the crest (\<3 mm), those in whom this thickness did not increase toward the lower border of the alveolar bone * patients with a history of infection or exposure after augmentation

Keywords: alveolar ridge augmentation horizontal augmentation bone block augmentation
identification of sentinel node(s) in breast cancer

Conditions: BREAST CANCER

Summary: the study is based on the identification of sentinel node(s) by sentimag / sienna + in addition to the usual method (blue and /or radioactive product). this is a feasibility study

* identification of sentinel node(s) 1. step 1: identification using the technique nanocis sub-areolar injection of tc99m-nanocis ® the day before or the day of surgery 2. step 2: identification using the technique sentimag ® / sienna+ injection sienna + ™ should be done just after induction of anesthesia and before the injection of patent blue dye 3. step 3: identification using the technique of patent blue dye or lymphotropic dye injection or patent blue is performed after induction of anesthesia, the injection and production sienna + ™, the operating theater by the surgeon * detection of sentinel node(s) 1. step 1: probe sentimag ® (study) 2. step 2: hand probe gamma radiation detection and / or colorimetric detection (standard) * sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown) * after the procedure: characterization of the size and weight of lymph nodes, histological and / or molecular osna and linking nodal status with the detection rate of sentinel nodes for each technique. nb: in case of synchronous bilateral cancer, 2 records are possible

Eligibility criteria:
inclusion criteria: * patient with invasive breast cancer or microinfiltrant proven by cytology and histo-or whatever the histological type * ct0/ct1/ct2 (up to 5 cm) cn0 clinical and / or ultrasound and without prior treatment (chemotherapy or neoadjuvant hormone ) * age greater than or equal to 18 * reporting of breast surgery and axillary staging of sentinel lymph node * using effective contraception (bhcg negative) * patient affiliated with a health insurance * consent signed by the patient exclusion criteria: * t3 or t4 tumors (\> 5 cm, cutaneous or muscle inflammation or cancer) * presence of a clinically suspicious axillary adenopathy or imaging * tumors bifocal or multifocal known before surgery * history of breast surgery or axillary * patient metastatic * patient with a cons-indication anesthesia and / or surgery * intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to patent blue dye in centers where it is commonly used * patient can not receive a radioactive isotope to the sentinel lymph node resection * allergy radioactive product * chronic iron overload * pacemaker or other implantable device in the chest wall * failure to submit to medical study for geographical, social or psychological * patient deprived of liberty or under guardianship * pregnant or lactating

Keywords: sentinel node
optic nerve sheath diameter in postspinal headache

Conditions: Post-Dural Puncture Headache

Summary: this study aims to investigate the relationship between spinal needle size and optic nerve sheath diameter (onsd) in patients who develop post-dural puncture headache (pdph) after spinal anesthesia. onsd is measured using ultrasound, which helps estimate changes in brain pressure. the study also examines whether the severity of headache is related to onsd. adult patients aged 18 to 75 years who develop pdph will be included. this research will be conducted at konya city hospital and is expected to last for approximately six months.

this prospective observational study investigates the relationship between spinal needle gauge and optic nerve sheath diameter (onsd) in patients who develop post-dural puncture headache (pdph) following spinal anesthesia. onsd is measured using ultrasound as a non-invasive marker of intracranial pressure. the study also aims to evaluate the association between headache severity, assessed by the visual analog scale (vas), and onsd values. patients aged 18-75 years with pdph will be included, and data on spinal needle gauge, onsd, and vas scores will be analyzed. the study is being conducted at a single tertiary care center and aims to contribute to understanding the physiopathology of pdph and its relation to procedural factors.

Eligibility criteria:
inclusion criteria: * patients diagnosed with postdural puncture headache (pdph) * male and female patients aged 18-75 years * patients classified as american society of anesthesiologists (asa) physical status i-iii exclusion criteria: * presence of neurological or ophthalmological disorders * history of head trauma within the past 6 months * hypertension * hepatic encephalopathy * renal failure * pregnancy * history of chronic headache or migraine * refusal to participate * inability to obtain reliable optic nerve sheath diameter (onsd) measurements * communication difficulties preventing assessment * incomplete or inaccessible medical records

Keywords: post-dural puncture headache (pdph) intracranial hypotension spinal anesthesia complication optic nerve sheath diameter spinal needle gauge
effectiveness of escitalopram in the treatment of body dysmorphic disorder

Conditions: Anxiety Disorders; Somatoform Disorders

Summary: this study's primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram.

we propose to conduct the first pharmacotherapy relapse prevention study in body dysmorphic disorder (bdd). bdd, an often-delusional preoccupation with a nonexistent or slight defect in appearance, is a distressing, impairing, and common body image disorder. it is associated with high rates of functional impairment and markedly poor quality of life. it appears that serotonin reuptake inhibitors (sris) are often--and selectively--efficacious for bdd and that many bdd patients receive sris. it also appears that most patients discontinue an efficacious sri at some point, as the alternative is life-long treatment. however, no relapse prevention studies have been done. such a study is important from a clinical and public health perspective, because bdd appears to often be chronic and require long-term treatment. it is therefore critically important to investigate the risk of relapse with sri discontinuation, and whether continuation sri treatment decreases relapse risk. subjects will be enrolled and first treated openly for 14 weeks with escitalopram; 58 escitalopram responders will then be randomized to double-blind continuation treatment with escitalopram or placebo for 6 additional months. our primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram. secondary/exploratory aims will explore 1) whether subjects who receive continuation escitalopram perform better on secondary outcome measures (e.g., quality of life) than those on placebo; 2) change in symptoms with continuation of escitalopram during the continuation phase; and 3) acute treatment response. in summary, this study will be the first relapse prevention study in bdd and the first study of continuation pharmacotherapy in bdd. it will provide critically important information on relapse with continuation versus discontinuation of an sri, whether continuation treatment protects against relapse, and change in symptoms with continuation treatment. this study will yield unique and clinically important data, and will fill gaps in knowledge about this common, severe, and understudied illness.

Eligibility criteria:
inclusion criteria: * outpatient men and women age 18 and older * diagnosis of bdd within 6 months of study start date based on the diagnostic and statistical manual of mental disorders (dsm-iv) * score of 24 or higher on the bdd-yale-brown obsessive compulsive scale * lives within driving distance of boston, ma or providence, ri exclusion criteria: * suicidal or homicidal tendencies * alcohol/drug abuse or dependence within 3 months of study entry

Keywords: body dysmorphic disorder escitalopram lexapro bdd body image
transcranial magnetic stimulation treatment for generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: we are investigating the feasibility and efficacy of transcranial magnetic stimulation (tms) for patients with gad who were placebo nonresponders in dief003523.1.

we expected to enroll five patients with gad who failed to respond to a sham (placebo) tms intervention. in this pilot study we enrolled three participants into a protocol including 10 rtms sessions (twice a week for five weeks) and one into a protocol including 15 rtms sessions (three times a week for five weeks). assessments occurred at pretreatment and at posttreatment.

Eligibility criteria:
inclusion criteria: * participated in the study dief003523.1, received sham "placebo" tms and achieved \< 50% improvement in hars at 3 month follow-up. * fluency in english * capacity to understand the nature of the study and willingness to sign informed consent form exclusion criteria: * history of epilepsy or head trauma (loc \> 5 minutes) within the past 6 months * lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery * a review of patient medications by the study physician indicates an increased risk of seizure * an active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency * substance use disorder or ptsd within the past 6 months * lifetime bipolar disorder, obsessive-compulsive disorder (ocd), psychotic disorder, mental retardation, or pervasive developmental disorder * any psychotic features, including dementia or delirium * concurrent psychotherapy and unwillingness to discontinue * medication change within the past 4 weeks * current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the past 6 months * serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study * any contraindication for participation in mri scan
low level laser (led) use to increase dental implant stability and post operative analgesia

Conditions: Implant; Analgesia

Summary: study hypothesis: low level laser (led) will reduce initial bone resorption and improve primary stability of dental implant. it will also reduces post operative pain compared to patient without treatment implant osseointegration depends on many factors including biocompatibility of implant materials, design, surface, surgical access, patient conditions, biomechanical status, and lack of primary stability. several in vivo and in vitro studies showed the healing effect of low level laser therapy (lllt) on bone by decreasing the initial bone resorption postoperatively and increasing the primary stability of the implant. it has also shown to have an analgesic effect intraorally when used post intraoral surgical procedures. the exact mechanism is unclear despite the fact that many hypothesis has been proposed. in our study, our goal is to present, in a randomized standardized clinical trial, the effect of lllt on post operative implant stability assessed by resonance frequency analysis (rfa). we will assess the subjective measures of postoperative pain using visual analog scale (vas).


Eligibility criteria:
inclusion criteria: * 1) english speaking exclusion criteria: * 1) systemic factors: diabetes, systemic immune disease, smoking (non-smoking is not absolute, but preferable.) * 2) local factors: no immediate implants, no grafting to the site, no other implants at separate location in the mouth around the same treatment period.

Keywords: dental implant initial stability initial bone resorption post implant placement analgesia effect of led intervention
a phase 3 study to evaluate the efficacy and safety of intravitreal ksi-101 in participants with macular edema secondary to inflammation (mesi) - peak

Conditions: Macular Edema Secondary to Inflammation

Summary: a phase 3 study to evaluate the efficacy and safety of intravitreal ksi-101 in participants with macular edema secondary to inflammation (mesi)


Eligibility criteria:
inclusion criteria: * mesi with a central subfield thickness (cst) of ≥400 microns on sd-oct in study eye. * bcva etdrs score of ≥25 and ≤70 letters (between 20/40 and 20/320 snellen equivalent) in the study eye. * diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the study eye. exclusion criteria: * me in the study eye secondary to diabetes, rvo, or wamd * active or suspected ocular or periocular infection in either eye

Keywords: mesi macular edema inflammatory macular edema macular edema associated with inflammation
prospective observational trial of iapa

Conditions: Influenza With Pneumonia; Pulmonary Aspergillosis

Summary: a prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (iapa) in icu patients and to identify host- and pathogen related risk factors for iapa in eortc negative icu patients with severe influenza.

invasive pulmonary aspergillosis was shown to be a complication of severe influenza infections in immunocompromised patients as well as in immunocompetent patients and is associated with a high mortality. antifungal prophylaxis might prevent influenza-associated pulmonary aspergillosis (iapa) and thus might improve the outcome in patients with severe influenza. however, clinical related risk factors should be identified to assess whether a patient will benefit from antifungal prophylaxis. this prospective multi-center observational study will assess the incidence of influenza-associated pulmonary aspergillosis (iapa) in icu patients in 12 icus in the netherlands, belgium and france over 4 influenza seasons. the secondary objective of this study is to identify host- and pathogen related risk factors for iapa in eortc negative icu patients with severe influenza. patients aged 18 or older admitted to the intensive care unit (icu) during the inclusion period due severe influenza without classic risk factors defined by the eortc will be included.

Eligibility criteria:
inclusion criteria: * patients with a pcr-positive respiratory virus panel (rvp) result for influenza within 96 hours before or 48 hours after icu admission. * patients who require icu admission for more than 24 hours for severe influenza. * patients who have respiratory distress (respiratory rate \>= 25x/minute and pao2/fio2 \< 300 with or without bilateral infiltrates) as the main reason for icu admission. * patients who do not have an eortc host factor. * patients who are at least 18 years of age. exclusion criteria: * patients with age \< 18 years as extensive sampling is required * expected survival on icu admission ≤ 48h * patients that are being treated actively with antifungal agents for invasive aspergillosis. * patients or their legal representatives who did not sign the informed consent form

Keywords: influenza intensive care unit influenza-associated pulmonary aspergillose invasive pulmonary aspergillosis virus diseases respiratory tract infections fungal lung diseases